All CDMO/CMO operations articles – Page 7
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NewsHow can PAT help advance biologics manufacturing?
Lonza’s Associate Director of R&D has offered insight on implementing process analytical technology (PAT) into biologics manufacturing using real-world examples.
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Webinar
Determining the right regulatory pathway for your drug
Understanding the different regulatory pathways available is critical to getting your drug to market as quickly and safely as possible.
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NewsWuXi Biologics proposes spin-off to support bioconjugate development
WuXi Biologics proposed spin-off and a separate HKEX listing of its subsidiary WuXi XDC means the company will be able to better capture the fast-growing global bioconjugate market.
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Whitepaperebook: Accelerate the development of your small molecule
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
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Video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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NewsLonza and Vertex to partner to manufacture diabetes cell therapies
The proposed collaboration between Lonza and Vertex Pharmaceuticals will support manufacture of stem cell-derived, fully differentiated insulin-producing islet diabetes cell therapies.
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VideoVideo: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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Whitepaper
Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
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NewsR&D innovation advancing small molecule innovator CDMO market
Accelerating advancement in research and technology is generating opportunities for biopharma to develop innovative small molecule drugs, a report shows.
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News6.1 percent CAGR expected for pharmaceutical sterility testing market
The rising importance of quality and sterility is expected to drive the pharmaceutical sterility testing market in the next decade, a report says.
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Whitepaper
Scientific journal: Reduce CNS drug development timelines by up to 40%
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.
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NewsPfizer and Samsung Biologics ink biosimilars manufacturing deal
Samsung Biologics has signed two long-term manufacturing agreements for Pfizer’s multiproduct biosimilar portfolio, worth $897 million.
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ArticleThe cell and gene therapy CDMO bottleneck isn’t capacity – it’s capability
CDMOs have been squeezed by the sharp increase in companies preparing to scale their cell and gene therapy manufacturing for Phase III trials and commercialisation, and physical capacity has been a common scapegoat. But eXmoor CEO Angela Osborne says the real limiting factor is experience.
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Webinar
Strategies for implementing eConsent across the European regulatory landscape
In this webinar, we dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.
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Webinar
Route scouting for a cost-effective process development
Watch this webinar to discover how route scouting and polymorph screening at early stages of clinical trials can support scale up to commercial manufacturing.
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Whitepaper
Scientific journal: Planning your first-in-human trial
This issue of The Altascientist provides a thorough review of the first-in-human clinical trial process, including planning and conduct.
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WhitepaperPress release: SGS launches SGS PACE, a streamlined pathway through preclinical, formulation, FIH and POC
SGS PACE is a seamless combination of world-leading development, bioanalysis and clinical research through one point of contact.
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Webinar
The hidden costs of microbial misidentifications
Doug Botkin, PhD, examines the challenges and consequences of inaccurate microbial identification methods using real-world case studies and discusses how these challenges can be addressed.
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NewsCGT supply chain and logistics market worth $3.12b by 2031
Improvements in real-time supply chain operations is expected to drive the cell and gene therapy supply chain/logistics market, a report says.
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NewsCollaboration to produce 3D screen printed pharmaceuticals
A new collaboration between two industry players for cGMP production of 3D screen printing technologies could reduce drug development costs.